PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays. The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC. Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wyraźna zgoda na uczestnictwo w badaniu i autoryzacja dostępu do danych zdrowotnych
- •Wiek co najmniej 18 lat
- •Potwierdzony rozpoznaniem raka piersi typu TNBC (potrójnie ujemny)
- •Zaawansowany nowotwór (stopień II/III) leczone chemioterapią przed operacją
- •Obecność resztkowego nowotworu po operacji
- •Badania obrazowe (np. tomografia) pokazujące brak przerzutów
- •Dostępne próbki tkanki z rozpoznania lub z operacji
- •Zdolność i chęć do uczestnictwa w procedurach badania
✗ Disqualifies
- •Ciąża lub karmienie piersią
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- April 22, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, United States
Trial contact
Taylor Pierce
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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